FDA 510(k) Application Details - K130003

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K130003
Device Name	System, X-Ray, Angiographic
Applicant	MIVENION GMBH ROBERT-KOCH-PLATZ 4 BERLIN 10115 DE Other 510(k) Applications for this Company
Contact	MALTE BAHNER Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2013
Decision Date	01/31/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review